FDA Inspection 1019235 — Medical Metrics, Inc.
The FDA completed an inspection of Medical Metrics, Inc. on February 27, 2017 in Houston, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 27, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2602 | 21 CFR 820.30(d) | Design output - review and approval |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |